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FDA recommendations on voluntary GE labeling

FDA recommends manufacturers use terms such as "not genetically engineered" or "not genetically modified through the use of modern biotechnology."

The Food and Drug Administration recognizes that many consumers are interested in whether food ingredients are derived from genetically engineered plants, and has issued guidance for manufacturers who wish to voluntarily label their foods as containing or not containing such ingredients.

If manufacturers wish to label their food as not being produced using genetic engineering, FDA recommends they use terms such as “not genetically engineered,” “not bioengineered,” or “not genetically modified through the use of modern biotechnology.”

FDA does not use the terms “genetically modified” or “genetically modified organism” (GMO) when referring to foods derived from genetically engineered plants.) FDA said it does not intend to take enforcement action against a label using the acronym “GMO” in a statement indicating that the product (or an ingredient) was produced through the use of modern biotechnology, as long as the statement was true and the food’s labeling is not otherwise false or misleading.

However, FDA encourages manufacturers to use labeling claims that state that a food product (or its ingredients, as appropriate) was not developed using bioengineering, genetic engineering, or modern biotechnology such as the claims included above. 

The “O” in the acronym “GMO” refers to the word “organism.” Most foods do not contain entire organisms (foods such as yogurt that contain microorganisms are exceptions); however, in some formulations this acronym may be read as meaning that the food was not derived from a genetically engineered organism, such as a plant that has been genetically engineered.  

FDA noted in light of potential confusion regarding the meaning of the acronym “GMO,” FDA encourages manufacturers to consider the use of other types of statements to indicate that a plant-derived food has not been produced using bioengineering. For example, a statement that “our tomato growers do not plant bioengineered seeds” or “this oil is made from soybeans that were not genetically engineered” could be used. 

Instead FDA uses the terms “genetic engineering” and “bioengineering” to describe the use of modern biotechnology. Modern biotechnology means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection of plants. The term “modern biotechnology” may alternatively be described as “recombinant DNA (rDNA) technology,” “genetic engineering” or “bioengineering.” 

In general, an accurate statement about whether a food was produced using bioengineering is one that provides information in a context that refers to bioengineering technology. Examples of such statements include:

  • “Genetically engineered” or “This product contains cornmeal from corn that was produced using modern biotechnology.”
  • “Some of our growers plant soybean seeds that were developed through modern biotechnology to be drought tolerant.” 

“These kinds of simple statements that a food was developed using bioengineering are not likely to be misleading,” FDA said in its guidance. 

A manufacturer that claims that a food product or its ingredients, including foods such as raw agricultural commodities, is bioengineered or is not bioengineered should substantiate that the claim is truthful and not misleading.  

Manufacturers should consider appropriate recordkeeping to document whether foods are or are not produced using bioengineering including segregation procedures to ensure that a food’s labeling is not false or misleading. Use of certified organic food also meets requirements to be labeled as not produced or handled using bioengineering. FDA also said the use of validated test methods may also be useful in confirming the presence of bioengineered material in food derived from genetically engineered plants or food ingredients.

The agency said it is not aware of any information showing that foods derived from genetically engineered plants, as a class, differ from other foods in any meaningful or uniform way. These foods also don’t present different or greater safety concerns than their non-genetically engineered counterparts. However, if a food derived from a genetically engineered plant is materially different from its traditional counterpart, the labeling of that food must disclose such differences.

FDA has required additional labeling of food derived from a GE source where it found that compositional differences resulted in material changes. For example, when FDA learned during a consultation that a specific canola oil had increased lauric acid content compared to conventional canola oil, the agency required the oil to be labeled “laurate canola oil.” Similarly, soybean oil containing higher levels of oleic acid than conventional soybean oil must be labeled “high oleic soybean oil.” Also, soybean oil containing significant levels of stearidonic acid must be labeled “stearidonate soybean oil” because stearidonic acid is not found in conventional soybean oil.

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